Kornimate/medical-research-clean huggingface dataset:
varenicline smoking cessation treatment for methadone maintenance patients

Conditions: Tobacco Use Disorder; Medication Adherence

Summary: this randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.

there is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. based on the information, motivation, and behavior model, the investigators plan a directly observed therapy (dot)-based intervention targeting behavioral skills necessary for optimal adherence. because methadone clinic-based dot interventions have been shown to improve medication adherence and clinical outcomes in hiv and tb, the investigators plan to determine in a randomized trial whether dot varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. the investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on dot effects. the investigators hypothesize subjects in the mdot arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. the investigators also hypothesize that adherence in the mdot arm will be higher than in the tau arm. lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mdot on adherence.

Eligibility criteria:
inclusion criteria: * age 18 years or older * english speaking * smoked at least 100 cigarettes/lifetime * smoke 5 or more cigarettes per day * interested in quitting smoking (preparation or contemplation stage of change) * enrolled in einstein/montefiore methadone program for 12 weeks or more * receiving methadone in clinic three, four, five or six times per week * no more than 2 methadone clinic misses in prior 14 days * agree to use contraception for the duration of the trial (among women with reproductive potential) * willing to participate in all study components * able to provide informed consent exclusion criteria: * serious or unstable hiv/aids, liver, cardiovascular, or pulmonary disease * psychiatric instability * women who are pregnant, breastfeeding, or contemplating pregnancy * creatinine clearance \<30 ml/min

Keywords: smoking substance-related disorders medication adherence methadone
comparisons of serologic response of early syphilis

Conditions: Serologic Response of Syphilis; Early Syphilis; High Risk Behavior

Summary: syphilis and hiv are prone to occur concomitantly and the two diseases share several modes of acquisition and risk factors such as men who have sex with men (msm), sexual workers, intravenous drug users, previous history of sexual transmitted diseases (stds), and multiple partners. hiv infection rates of up to 50% have been reported among patients diagnosed with syphilis in several regions, with higher hiv infection rates among msm. besides, syphilis ulcers are proposed to enhance the transmission of hiv. in taiwan, there is also an increasing prevalence of syphilis and hiv co-infection among msm. therefore, to treat syphilis is an important issue for public health. according to literature review, whether patients with hiv and syphilis co-infection had higher serologic failure rate remains controversial, especially in the era after highly active anti-retroviral therapy (haart) was introduced since 1996. ghanem et al recently demonstrated that the use of haart may reduce syphilis failure rates among hiv-infected patients who have syphilis. in addition, the treatment guideline in 2006 suggested that the treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin g regardless of hiv status; however, it goes on to suggest that "some specialists recommended additional treatments for hiv-infected patients", namely 3 doses, each a week apart. there is no reference and evidence of strength of the suggestion but only specialists' opinion. in the study, we aim to compare serologic response of syphilis to penicillin treatment between hiv-infected and hiv-uninfected patients and to compare serologic response of early syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin g among hiv-infected patients. a longitudinal follow-up of serologic response will be conducted after syphilis treatment.


Eligibility criteria:
inclusion criteria: * persons aged ≧20 year-old, who had documented syphilis infection (rpr titer≧ 1:4 and tppa ≧1:320) exclusion criteria: * nil

Keywords: syphilis; human immunodeficiency virus; penicillin
denosumab vs alendronate after vertebroplasty

Conditions: Denosumab Allergy

Summary: osteoporotic vertebral compression fracture (ovcf) patients had a proportion of secondary fractures after percutaneous vertebroplasty (pvp). denosumab and alendronate is both effective to prevent bone loss for ovcf postmenopausal women. however, trial evidence comparing effect of denosumab vs zoledronate after pvp was unknown. the study aims to assess the efficiency of denosumab vs alendronate for ovcf patients bone mineral density (bmd), bone turnover markers (btms), secondary fracture and adverse events after pvp

whether denosumab was non-inferior than alendronate in improving bone mineral density (bmd), bone turnover markers (btms), functional status questionnaires, and secondary fracture in elderly patients with ovcf after pvp remains unknown. a prospective, randomized, placebo-controlled clinical trial in ovcf patients with pvp was performed. this study aimed to investigate the efficiency of denosumab vs alendronate on bmd, btms, functional status, secondary fracture rate, and adverse events in ovcf patients after pvp during a 12-month follow-up period.

Eligibility criteria:
inclusion criteria: * must be age between 50 and 85 years old * x-ray diagnosis of 1 or 2 segment vertebral compression fractures from t4 to l5 * bone mineral density t value less than -1 via dual-energy x-ray * a recent fracture history less than 6 weeks * mri show bone marrow edema of fractured vertebrae * low back pain, local paravertebral tenderness exclusion criteria: * must be able to have no intervertebral fissure * must be able to have no infection * must be able to have no malignancy * must be able to have no neurological dysfunction * must be able to have no previous use of anti-osteoporosis drugs * must be able to have no inability to perform magnetic resonance imaging * must be able to have no prior back open surgery * must be able to have no other established contraindications for elective surgery
prevention of delirium in icu using multimodal interventions

Conditions: Intensive Care Unit Delirium

Summary: this study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.

delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. however there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. researches also have focused on the prevention of delirium or the reduction of duration of delirium. several studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. however, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for korean patients. a randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in korea.

Eligibility criteria:
inclusion criteria: * adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit exclusion criteria: * patients who developed delirium before entering the intensive care unit * patients with cognitive impairment * patients who have hearing or vision deficits, or have difficulty in communication * patients who are expected to die within 24 hours or do not want life-sustaining treatment

Keywords: delirium intensive care unit non-pharmacological intervention
yoga for veterans with clbp

Conditions: Chronic Low Back Pain

Summary: chronic low back pain (clbp) is a prevalent condition among va patients, but many current treatment options have limited effectiveness. in addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. this randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in va patients with chronic low back pain. although not every va patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many va patients. if yoga is effective, it could become an additional low-cost option that the va can offer to better serve veterans with chronic low back pain.


Eligibility criteria:
inclusion criteria: * has a va primary care provider * diagnosis of chronic low back pain \> 6 months * willing to attend a yoga program or be assigned to delayed treatment with yoga * willing to complete 4 assessments * english literacy * has not begun new pain treatments or medications in the past month * willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary exclusion criteria: * back surgery within the last 12 months * back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia) * morbid obesity (bmi \> 40) * significant sciatica or nerve compression \ 3 months * unstable, serious coexisting medical illness (eg, chf, cancer, copd, morbid obesity; dementia) * unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence) * insufficient data to rule out acute, metastatic disease, (unless primary care physician approves) * attended or practiced yoga \> 1x in the last 12 months * positive romberg test (with or without sensory neuropathy)

Keywords: yoga mind-body therapies chronic low back pain military veterans va patients
effectiveness of visual storytelling intervention on antibiotic adherence in uti patients

Conditions: Uncomplicated Urinary Tract Infection; Patient with Uncomplicated UTI

Summary: this study aims to evaluate the effectiveness of a visual storytelling intervention in improving antibiotic adherence among adults with urinary tract infections (utis). participants will be randomly assigned to either the intervention group, where they will receive a visual pamphlet explaining the importance of completing their antibiotic course, or the control group, which will receive routine care. the study will measure how well participants follow their prescribed antibiotic regimens and assess their knowledge and attitudes toward antibiotic use. the goal is to determine if visual storytelling can enhance adherence, reduce antibiotic resistance, and improve health outcomes.

this randomized controlled trial (rct) will assess the impact of a visual storytelling intervention on antibiotic adherence among adults diagnosed with uncomplicated urinary tract infections (utis). the intervention involves a visually engaging pamphlet that educates patients on the importance of completing their prescribed antibiotic course and the consequences of non-adherence, such as antibiotic resistance. participants will be randomly assigned to either the intervention or control group, with the control group receiving standard care (e.g., verbal or written instructions). the primary outcome is adherence to the antibiotic regimen, measured by pill counts. secondary outcomes include uti recurrence, knowledge about antibiotic use, and attitudes toward antibiotic treatment. data will be collected at baseline, immediately after the intervention, and at follow-up visits over 1, 3, and 6 months. this study seeks to determine if visual storytelling can improve antibiotic adherence and help combat antibiotic resistance.

Eligibility criteria:
inclusion criteria: 1. adults aged 18 years or older. 2. physician-confirmed diagnosis of uncomplicated urinary tract infection (uti). 3. prescribed oral antibiotics (tablet/capsule) for uti treatment. 4. willingness to participate in the study and provide informed consent. 5. ability to complete follow-up assessments and adhere to the study protocol. exclusion criteria: 1. diagnosed with complicated uti (e.g., pyelonephritis, sepsis, or structural abnormalities). 2. multiple comorbidities that require polypharmacy. 3. cognitive impairment or mental disorders that would interfere with study participation. 4. pregnant or breastfeeding women. 5. participation in another clinical trial that could interfere with this study.

Keywords: visual storytelling antibiotic adherence uti recurrence
platelet-rich plasma use as prophylactic of low back pain post-spinal following gynecological surgery

Conditions: Platelet-rich Plasma in Low Back Pain

Summary: platelet-rich plasma use as prophylactic of post-operative low back pain following gynecological surgery.


Eligibility criteria:
inclusion criteria: * elective gynecological surgery. exclusion criteria: * spinal pathology
a study to evaluate safety and tolerability of olipudase alfa in pediatric and adult participants with acid sphingomyelinase deficiency (asmd) who completed the dfi12712 or the lts13632 study in france

Conditions: Niemann-Pick Disease

Summary: this is an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ert) with olipudase alfa to patients with acid sphingomyelinase deficiency (asmd) who completed the dfi12712 or the lts13632 study in france until olipudase alfa reimbursement is granted in france. study and treatment duration: the period between the patient's completion of study dfi12712 or lts13632 and olipudase alfa reimbursement is available in france. in case reimbursement will not be obtained, this study will end 5 years after starting. visit frequency: every 2 weeks.


Eligibility criteria:
inclusion criteria: * the patient has completed study dfi12712 (ascend) or lts13632 in france * the patient must provide signed, informed consent prior to performing any study-related procedures. * the patient is willing to comply with the clinical protocol. * the patient, if female and of childbearing potential, must have a negative pregnancy test result \[urine beta-human chorionic gonadotropin (β-hcg)\] at enrollment. * sexually active female patients of childbearing potential and male patients are required to practice true abstinence in line with their preferred and usual lifestyle or to use 2 acceptable effective methods of contraception for the entire duration of the treatment period and for at least 28 days after receiving the last study drug dose. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any patient who has not participated in the study dfi12712 or the study lts13632 * a patient who experienced any systemic hypersensitivity reactions to olipudase alfa in study dfi12712 or study lts13632 which, in the opinion of the investigator, could indicate that treatment continuation may present an unreasonable risk. * the patient, in the opinion of the investigator, is unable to adhere to the requirements of the study. * the patient is unwilling or unable to abstain from alcohol for 1 day prior to and 3 days after each olipudase alfa infusion for the duration of the treatment period. * individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. * the patient is concurrently participating in another clinical study of investigational treatment. * any of the following medical conditions: * the patient has any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient's participating in or completing the study. * requirement for recurrent dose adjustment of anticoagulation treatment over the last 6 months. * pregnancy or breastfeeding. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
polish validation 4at tool

Conditions: Delirium, Postoperative; Surgical Procedure

Summary: delirium is a phenomenon which affects patients with various disorders and representing various age groups. screening instruments make it possible to diagnose the condition at an early stage and to prevent its development. the aim of the study is to examine the reliability and validity of the polish version of the 4at (pol4-at) in patients after cardiac surgery. procedure of validation: after obtaining the author's consent, the original english version of the 4at was separately translated by 3 centres working on the validation of the pol4-at (university of rzeszów, poland; university hospital in england; karolinska university, sweden). then, three translations were compared, to be approved by the project supervisor (karolinska university). any doubts arising during the comparison were consulted with the english translator. as a result, one coherent version was accepted and translated back into english. the questionnaire was distributed in a convenient sample of 20 patients to examine the validity of the face. vague words and statements were changed, and the final version translated into polish was created. the pol4-at was tested for internal consistency and reliability.

delirium, which generally is triggered by underlying medical conditions, is an acute and fluctuating disorder associated with attention and cognitive defects, and frequently accompanied by excessive arousal and perception-related problems. delirium may lead to a variety of complications, e.g. cognitive impairments. development of delirium is promoted by both anaesthesia and pain. patients subjected to cardiac surgeries are at risk of delirium due to such factors as extracorporeal circulation applied during the intervention and various cardiovascular complications. rapid identification of the problem may help eliminate avoidable complications which can be prevented at an early stage.

Eligibility criteria:
inclusion criteria: * adults * able to sign the consent form * elective cardiac surgery * extracorporeal circulation exclusion criteria: * unconscious patients * diagnosed mental illness * patient's lack of consent to participate in the study

Keywords: delirium 4at scale cardiac surgery validation
clinical study comparing different strategies to increase adherence to oral therapies in oncohematology

Conditions: Cancer; Solid Tumor; Hematologic Malignancy; Oral Drug Administration

Summary: this is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management. a total of 124 patients will be considered. patients will be randomized 1:1 to one of the following interventions: a. electronic diary b. paper diary the primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors.

this is a multicenter, interventional, non-pharmacological study on a app for oral anticancer therapy management. the primary aim of the study is to assess the effectiveness of the electronic diary in improving adherence to oral therapy treatment compared to the paper diary, in patients with solid and haematological tumors. the secondary objectives of the study are: 1. describe the reasons for non-adherence in each group (eg. forgetfulness, side effects, misunderstanding of prescription), 2. describe the patient's compliance with the instrument and modalities (electronic diary, paper diary) through a short questionnaire 3. description of the costs related to therapeutic non-adherence. a total of 124 patients will be considered: enrollment will take place consecutively until the predetermined number is reached. eligible patients will be randomized in a 1:1 ratio using a balanced procedure a blocks exchanged to one of the following interventions, stratified by type of therapy (chemotherapy vs. biological therapy): a. electronic diary b. paper diary the electronic diary consist of an android app (for android version 2.2 and later) for mobile devices, which acts as a diary for the patient. adherence will be assessed at each treatment cycle by counting the remaining tablets. for patients with disease progression within six treatment cycles, the assessment of adherence and therefore the count of the remaining tablets will end on the date of progression.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old (both genders) * eastern cooperative oncology group (ecog) ≤2 * patients with solid and haematological neoplasia (adjuvant or advanced setting) candidates to treatment with oral therapy. exclusion criteria: * patients who also receive anticancer treatment intravenously, as such patients access the hospital regularly and are in closer contact with healthcare personnel. * patients receiving experimental cancer treatment * patients who are unable to cooperate with study procedures (in the researcher's opinion) * patients who are candidates for oral drug treatment lasting less than 3 months. * patients with a life expectancy \<12 weeks. * all patients being treated with drugs not listed in the protocol appendix c.

Keywords: cancer oral therapy mobile app electronic diary